FDA Approves New Option for Difficult-to-Treat Heart Failure

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The U.S. Food and Drug Administration has approved finerenone (Kerendia) to reduce the risk of cardiovascular death, hospitalization and urgent care visits for adults with heart failure with a left ventricular ejection fraction of 40% or higher, Bayer announced on July 14.

The approval marks a major expansion in use for the drug, which was previously approved for chronic kidney disease associated with Type 2 diabetes. This decision now allows finerenone to be prescribed for people with heart failure with mildly reduced or preserved ejection fraction, conditions that affect millions of adults in the U.S. and have historically had few treatment options.

FINEARTS-HF Trial Shows Reduced Risk of Hospitalization

The FDA’s decision was based on results from the FINEARTS-HF trial, a Phase 3, international, randomized study involving more than 6,000 adults with an ejection fraction, which is a measure of heart function detailing the percentage of blood pumped out of the heart’s ventricles with each heartbeat, of at least 40% and New York Heart Association (NYHA) class II–IV heart failure. Patients in the trial were followed for up to 42 months.

Participants in the study had an average ejection fraction of 53%. Most were already receiving standard therapies such as beta-blockers and, to a lesser extent, SGLT2 inhibitors or renin-angiotensin system blockers. Nearly 70% were classified as NYHA class II, meaning they had mild limitations of physical activity but still showed clear symptoms of heart failure

The study found that finerenone reduced the risk of cardiovascular death or heart failure events, including hospitalizations and urgent visits, by 16% compared with placebo. Hospitalizations specifically were reduced by 18%. However, the 7% reduction in cardiovascular death alone was not statistically significant.

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of (at least) 40% — a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, M.D., professor of medicine at Harvard Medical School, director of the Clinical Trials Outcomes Center at Mass General Brigham and chair of the Executive Committee for the FINEARTS-HF study. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

A New Option for Patients With Limited Choices

Patients with normal or preserved ejection fraction account for approximately half of all heart failure cases, but these patients have seen fewer advances in treatment compared with heart failure with reduced ejection fraction. In comparison with those with reduced ejection fraction, many patients with preserved ejection fraction are older, are more likely to be women and often live with multiple chronic conditions, making treatment complex.

Finerenone is part of a class of drugs known as nonsteroidal mineralocorticoid receptor antagonists (MRAs). While steroidal MRAs like spironolactone are already used in heart failure, they can cause side effects such as elevated potassium or kidney dysfunction. According to cardiologist Marat Fudim, M.D., an advanced heart failure specialist at Duke University, the better tolerability of finerenone could make it a more appealing option for many patients.

“I prescribe (MRAs) to every (heart failure with preserved ejection fraction) patient, but they’re often the first to come off because it has quite a bit of a side effect profile,” Fudim said. “Solely on the fact that it has a better side effect profile and also has more definitive data. It’s just going to be a much more exciting therapy option.”

The drug will join SGLT2 inhibitors as part of a growing set of therapies for heart failure with preserved or mildly reduced ejection fraction. In many cases, clinicians may consider combining these treatments for better outcomes.

Ongoing Research to Broaden Understanding

The approval comes as Bayer continues its global MOONRAKER heart failure research program, which includes more than 15,000 participants across four clinical trials. These studies are evaluating finerenone in a range of heart failure populations, including those recently hospitalized or unable to tolerate steroidal MRAs.

Despite its positive results in reducing hospitalizations, the FINEARTS-HF trial did not show statistically significant improvements in all-cause mortality or kidney-related outcomes. Still, the overall findings suggest meaningful benefits for many patients with symptomatic heart failure with preserved ejection fraction.

“Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or (cardiovascular) death, and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge,” said Alanna Morris-Simon, M.D., M.Sc., senior medical director at Bayer, in a news release. “Now, as a core pillar of treatment, (finerenone) can help patients reduce these risks.”